Lot release

Each individual lot of a licensed drug product must be evaluated and approved prior to its release on the market. The regulatory authorities demand review of manufacturer's production data and results of quality control testing.

Quality control testing by a contracted laboratory, supports lot release by providing evidence of a guaranteed level of safety and quality of the released product, by a third, independent and impartial party. As an independent contracted laboratory, IBR Inc. supports lot release of biologics, biosimilars, vaccines and small molecules by means of a broad panel of bioanalytical services. Meeting customer production schedules is a key feature of our business.

IBR Inc. lot release services

Lot release at IBR Inc. is performed following the EU GMP requirements and the specifications for test procedures and acceptance criteria described in the ICH Q6 guidelines (Q6A for new drug substances/new drug products and Q6B for biotechnological/biological products categories, respectively) and in the ICH Q1A and Q5C guidelines for stability testing (Q1A, R2 for new drug and Q5C for biotechnological/biological products categories, respectively). Read more about Quality Standards at IBR Inc.

Featured assays

Find a summary of assays to support lot release:

 

  • Cell-based assays and cell-based (MSD ECL)
  • Immunoassays (ELISA, Alpha Technology, Gyrolab, MSD ECL)
  • Ligand-binding assays (ELISA, MSD-ECL, Alpha Technology, Gyrolab)
  • Cell binding assays (FACS, MSD-ECL, HTRF)
  • Cytokine release assays (FACS, MSD-ECL)
  • Neutralization assays
  • Endocytosis and internalization assays (FACS)
  • Proliferation assays
  • Immune cell infiltration assays (3D biomimetic systems)
  • Antigen-specific immune response
  • Apoptosis/cytotoxicity assays
  • Adhesion and migration assays
  • Luciferase reporter gene assays
  • FcγR and FcRn binding assay (AlphaLISA, ELISA)
  • C1q binding assay (ELISA)
  • CDC, ADCC and ADCP
  • Protein content/concentration (A280 UV/VIS spectrophotometry, Bradford Assay, BCA/Smith Assay UV/VIS based)
  • Sterility testing (non GxP, GMP outsourced)
  • Stability testing: stress conditions (e.g. high temperatures and/or humidity)
  • 1D and 2D SDS-PAGE
  • Host cell protein (HCPs) determination (ELISA)
  • Western blot and 2D PAGE Western immunoblotting (IEF) analysis
  • Determination of impurities (immunoassay, size exclusion HPLC)
  • Endotoxin determination: colorimetric endpoint and kinetic approaches
  • Host cell DNA determination by quantitative PCR (Taqman)
  • Appearance, osmolality, pH

 

IBR Inc. offers diverse technology and methodologic solutions to face a variety of challenges related to lot release. Contact us to select the best solution tailored to your specific needs.

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